ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31301 results sorted by trial registration date.
  • A randomised control trial of Social Skills Training (SCIT) in those diagnosed with psychosis.

    The social cognition training (SCIT) is a groupbased therapy that has a goal of improving thinking skills about social situations for individuals with psychotic disorders. Two trained therapists deliver the group over 12 weekly sessions, with each session lasting approximately 2 hours. Participants will be able to attend one of the sites convenient to where they live. The therapy involves education about emotions and social interaction using games and technology such as watching DVD’s. Participants will be asked to attend a clinical assessment at three times points (beginning of the study, end of study and 3 months post study)that will take approximately 2 hours of their time. The clinical assessment will include tests of thinking and problem solving skills, and questions about how people think in social situations and skills in identifying emotions from photographs of people. At the completion of the entire study, a summary of the results will be sent out to participants informing them of the outcomes of the study.

  • Stability, functional and clinical outcomes following Reverse Total Shoulder Arthroplasty (RSA); Repair versus Non-Repair of the Subscapularis

    The importance of the subscapularis in patients with a Reverse Shoulder Arthroplasty prosthesis and consequently, the need of repair following implantation, remains controversial. The aim of the study is to determine the stability, functional and clinical outcomes of a repaired versus non-repaired/irreparable subscapularis following Reverse Total Shoulder Arthroplasty. The primary objective of this study is to assess the difference in the function, as measured by the self-reported ASES score, between two RSA treatment groups up to 5 years post-surgery. Secondary objectives are to: Compare outcomes of patients implanted with a medialised versus lateralised Reverse Total Shoulder prosthesis between the two treatment groups. Consider the influence of scar tissue development on functional and clinical outcomes between the two treatment groups. A physiotherapy focused substudy will evaluate the intra- and inter-rater reliability of range of motion (ROM), manual muscle testing (MMT) and hand held dynamometry (HHD) strength testing for assessment of Reverse Total Shoulder Arthroplasty patients.

  • Functional MRI assessment of primary and secondary brain tumour response to radiation therapy: A pilot study

    This pilot study will determine the relationship between of pre-, during treatment and post-radiotherapy (+/- chemotherapy) MRI sequences (including DW and DCE-MRI) with respect to CNS tumour response and local intra-cranial control, post radiotherapy. and also determine the utility of MRI for assessing changes to the hippocampal region from CNS radiation therapy Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with primary or secondary brain cancer. Study details Participants will undergo normal MRI testing at baseline with an addition of 3 more times. During RT (Week 3 and 6) and then again 4 weeks post RT

  • Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Subcutaneous APL-9 in Healthy Volunteers

    APL-9 is a PEGylated peptide wherein a small pharmacologically moiety binds to primate complement C3 and exerts a broad inhibition of the complement cascade. The PEG portion of the drug molecule imparts longer residence time in the body after administration of the drug. APL-9 for SC injection is currently in development as a potential treatment for paroxysmal nocturnal hematuria (PNH), which is an acquired hematological disease characterized by complement-mediated red blood cell (RBC) hemolysis, with or without hemoglobinuria, and increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction. This single ascending dose study is the first study in a planned series of studies for the clinical development of APL-9. The primary objective of the study is to assess the safety and tolerability of single subcutaneous (SC) doses of APL 9 in healthy volunteers. The secondary objective of the study is to assess the pharmacokinetics (PK) of single SC doses of APL 9 in healthy volunteers. An exploratory objective of the study is to assess the pharmacodynamics (PD) of single SC doses of APL 9 when administered to healthy volunteers. The study will recruit 21 subjects in four dose cohorts. Subjects will participate in only one cohort and will receive a single dose of APL 9 or placebo administered subcutaneously. Safety will be assessed throughout the study; serial blood samples and urine samples will be collected for these assessments. Blood samples will also be collected for the PK, PD, and immunogenicity assessment of APL 9. Dose escalation to the next dose level (i.e. next cohort) will not take place until a Safety Monitoring Committee (SMC) comprised of the Principal Investigator (PI), the Medical Monitor, and the Sponsor have determined that adequate safety and tolerability from the previous cohort has been demonstrated to permit proceeding to the next cohort. Subjects will be resident in the clinical facility (Nucleus Network Ltd) from the day before dosing until 168 hours (Day 8) after dosing. Subjects will return for follow-up visits and the exit visit for subsequent study procedures.

  • Quantity of IV insulin required to keep blood glucose levels within target range after a high protein/high fat meal.

    Clinical experience and reports from families of children with type 1 diabetes has long suggested that meals high in protein and/or fat cause an increase in blood glucose levels after eating. Increased blood glucose levels, including after consumption of food, is well-known to add to long term health complications in type 1 diabetes. Current type 1 diabetes management guidelines recommend adjusting insulin doses for food based on the amount of carbohydrate to be eaten at each meal. However, there has been an increase in evidence, including that from a lanmark study by our study group, to suggest that other nutrients such as fat and protein should be considered when calculating pre meal insulin. High levels of protein and/or fat in a meal cause a larger than expected rise in blood glucose levels after eating and these high blood glucose levels persist, suggesting the need for extra insulin. This research project will compare the insulin required to maintain blood glucose levels within target range when consuming two meals, one high in protein and fat and the other low in protein and fat, both with the same carbohydrate content. This will be determined by looking at the difference in intra venous insulin requirements after both meals. IV insulin will be given to participants to maintain blood glucose levels at a constant level whilst they are eating the meal and in the 5 hours following. Thirteen participants will consume both test meals, one week apart. The different insulin amounts needed to maintain blood glucose levels after each test meal will provide accurate calculation of the expected increase in insulin requirements on consumption of a high protein/high fat meal. This study will provide important information in the management of type 1 diabetes in both adults and children. This information will be used immediately in our day to day management of patients and will guide the development of clinical guidelines to minimize the rise in blood glucose levels after eating.

  • Efficacy of the Triple P Parenting Intervention for Migrant and Former-Refugee Parents: Randomized Controlled Trial

    This study will answer the research question of whether receiving contextually and culturally appropriate parenting support early in the settlement period can improve adjustment in migrant and former-refuge families, and by extension, facilitate positive sociocultural adaptation. The aims of the project are to: (a) Determine whether parental participation in a Triple P intervention within the first five years of settlement is effective at improving migrant and former-refugee family outcomes, and (b) Evaluate the efficacy of the program for improving sociocultural adjustment and reducing acculturative stress in migrant parents. The rigorous methodology being utilised in the current study will provide a strong indication as to the generalizability of the results to migrant and former-refugee families in other geographic regions. Should the intervention prove to be effective, it has the potential to fill an important research and service gap, providing an innovative, cost-effective, and evidence-based means to strengthen family relationships and promote positive adjustment in migrant children and their parents.

  • The efficacy of mangosteen pericarp fruit extract for the treatment of schizophrenia.

    There is evidence of anomalies in redox biology in schizophrenia; (i) the presence of oxidative stress (where the levels of antioxidants are decreased or the levels of free radicals are increased to a point that is damaging to the function of the cell, increasing inflammation) particularly implicating the glutathione system ; (ii) changes in oxidative status with treatment; and (iii) evidence that other glutathione and redox active agents have therapeutic value. Garcinia mangostana Linn, known colloquially as mangosteen, is a tropical evergreen fruit tree originating from Indonesia. Its rind or pericarp contains an exudate containing a large number of bioactive compounds called xanthones that have robust effects on the glutathione system and many other pathways germane to schizophrenia. Motivated by the results of the first pilot randomised, double blind placebo trial of adjunctive Garcinia mangostana Linn for the treatment of schizophrenia we speculate that this research may uncover a new class of agents for the treatment of the disorder, and uncover novel pathophysiological pathways. The trial involves 150 participants aged 18 years or older with a DSM-V diagnosis of schizophrenia or schizoaffective disorder. Participants referred to the trial will have an initial face–to-face screening interview. All randomised participants will receive two 500mg mangosteen pericarp capsules once a day to a total dose of 1000mg daily or placebo, in addition to treatment as usual, for 24 weeks. Assessment will occur at regular 4 weekly intervals throughout the 24 weeks and 1 month after completion of the study. The primary outcome will be the change in schiaophrenia symptom severity using the PANSS total scale at the end of the 24-week treatment phase. The secondary outcomes will include changes in depressive symptoms, quality of life, functioning and life satisfaction which will be measured using the PANSS subscales, Q-LES-Q scale, GAF, LIFE-RIFT, PGI and Cogstate. Blood biomarkers will also be analysed. Blood samples will be obtained at baseline and week 24. Blood will be analysed for relevant markers based on preclinical evidence including markers of antioxidant defence, oxidative stress and markers of inflammation. The research will have immediate and direct translational benefits. The safety and tolerability of Garcinia mangostana Linn, its affordability and accessibility and that the general public are accepting of plant-derived compounds, raise its attraction as a potential therapeutic agent.

  • Culturally informed assessment and treatment of chronic pain

    Primary aim: The aim of this project is to pilot a culturally adapted physiotherapy assessment and treatment approach for use with three CALD communities living in Australia and contrast it with ‘usual’ evidence based physiotherapy care. This project will seek to identify aspects of trial design that may need to be modified in a larger RCT. This includes establishing community acceptance and satisfaction with the novel treatment approaches and determining community willingness to participate in randomised research. It will also generate outcome data that will be used for sample size estimates and predicting the magnitude of treatment effects for a future clinical trial. Hypothesis It is hypothesised that the culturally adapted approaches will be well accepted by participants and significantly more effective at improving function, burden of suffering and patient adherence, when compared to usual care. Proposed research design Pilot Randomised Controlled Trial. Two group pre-test, post-test design. Methods: Potential participants will be identified from physiotherapy wait-lists and assessed to ascertain eligibility for trial inclusion. Those who meet the inclusion criteria and consent to participate will be randomly assigned to either the culturally adapted physiotherapy treatment or evidence based usual physiotherapy care. The culturally adapted physiotherapy treatment approach will be a combination of group physiotherapy education and exercise, and individual treatment. Participants allocated to this treatment arm will attend a group session for two hours a week, for six weeks and up to four individual sessions over three months with a qualified physiotherapist. The control group is evidence based usual care and will include treatment by a qualified physiotherapist who has not been trained in cultural adaptation methods. Participants randomised to this treatment arm will attend up to ten physiotherapy sessions that incorporate evidenced based physiotherapy management, over three months. Data that will help determine the feasibility of future trials will be collected including recruitment rates, drop-out rates, adherence and patient satisfaction will be collected at three months. Physical performance outcomes (six minute walk distance and the number of sit to stand’s performed in 1 minute) and pain related questionnaires (Brief Pain Inventory, Pictorial Representation of Illness and Self-Measure, Depression Anxiety and Stress Scale) will collected at pre and post treatment to inform treatment efficacy.

  • A Single Infusion Study of DUR-928 in Healthy Volunteers

    This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intravenous infusion to healthy volunteers. The study will look at the study drug’s safety and tolerability when given as a single dose at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream).

  • Central Australian Diabetic Maculopathy Study: Treatment Patterns and Outcomes

    Macular oedema (swelling of the central retina) is the commonest cause of visual loss in people with diabetes. Monthly injections of Anti VEGF are superior to conventional laser treatment when there is moderate visual loss from central macular oedema. However, monthly injections are less practical in central Australia and laser may be more effective than injections in many common clinical scenarios. Our pilot audit showed that results from laser in central Australia were equivalent to some of the original published cohorts of laser treatment. This study planned to audit results of laser treatment for diabetic maculopathy in central Australia over a longer period, and identify scenarios where laser remains an effective and affordable option in the treatment of diabetic maculopathy

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